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Bethesda North Marriott Hotel and Conference Center

Apr 24, 2018 7:00 AM - Apr 25, 2018 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling Conference

Session 6: Impact of EU GVP Module IX on Global Labeling Goverance

Session Chair(s)

A. Leander  Fontaine, MD

A. Leander Fontaine, MD

President

Pharmiceutics, LLC., United States

This session discusses the potential implications of the safety-labeling submission requirements added to the revised EU GVP Module IX on companies’ global labeling actions, policies, and processes.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the new requirements for the timing of safety labeling variations in GVP Module IX (Rev. 1)
  • Analyze the potential impact on their company’s labeling global process

Speaker(s)

Barbara  Lachmann, MD

The Revised GVP Module IX and its Potential Impact on Global Labeling Processes - Introduction

Barbara Lachmann, MD

Barbara Lachmann Labeling Consulting, Germany

Sole Proprietor

Elisabethann  Wright

Understanding the Labeling-Related Requirements of the Revised GVP Module IX

Elisabethann Wright

Hogan Lovells International LLP, Belgium

Partner

Lynn W. Mehler, JD

The New Labeling Submission Requirements in GVP Module IX – A USA Legal Point of View

Lynn W. Mehler, JD

HoganLovells, United States

Partner

Shinobu  Uzu, PhD

Panelist

Shinobu Uzu, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Senior Executive Director

Deborah  Bebbington

Panelist

Deborah Bebbington

Bayer Plc, United Kingdom

Head Global Labeling

Kiernan  Trevett, MSc

Panelist

Kiernan Trevett, MSc

Genentech, A Member of the Roche Group, United States

Quality Policy Lead

Paula  Hudson, RPh, RAC

Panelist

Paula Hudson, RPh, RAC

Eli Lilly and Company, United States

Director, Global Labeling

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